[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649136":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":52,"collaborators":54,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":87,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Barcelonabeta Brain Research Center, Pasqual Maragall Foundation","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Multimodal Lifestyle Intervention + EGCG",null,"Participants who completed the original PENSA trial and were assigned to the intensive personalized multimodal lifestyle intervention combined with epigallocatechin gallate (EGCG) supplementation for 12 months. The intervention included dietary counseling, physical exercise, cognitive training, psychoeducation, social stimulation, and vascular risk management. Participants are followed approximately 5 years after completion of the intervention (current PENSA+ study) to evaluate long-term cognitive, biological, lifestyle, and health outcomes.",{"label":13,"type":10,"description":14,"interventionNames":10},"Multimodal Lifestyle Intervention + Placebo","Participants who completed the original PENSA trial and were assigned to the intensive personalized multimodal lifestyle intervention combined with placebo supplementation for 12 months. The intervention included dietary counseling, physical exercise, cognitive training, psychoeducation, social stimulation, and vascular risk management. Participants are followed approximately 5 years after completion of the intervention (current PENSA+ study) to evaluate long-term cognitive, biological, lifestyle, and health outcomes.",{"label":16,"type":10,"description":17,"interventionNames":10},"Control","Participants who completed the original PENSA trial and were assigned to the control group, receiving general healthy lifestyle recommendations without the intensive multimodal intervention. Participants are followed approximately 5 years after completion of the original study (current PENSA+ study) to evaluate long-term cognitive, biological, lifestyle, and health outcomes.",[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Natàlia Soldevila Domènech, MPH, PhD","CONTACT","(+34) 93 316 09 90","nsoldevila@barcelonabeta.org",[25],{"facility":26,"status":10,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Fundació Pasqual Maragall","Barcelona","Catalonia","08005","Spain","ES",{"type":33,"coordinates":34},"Point",[35,36],2.15899,41.38879,{"lat":36,"lon":35},[39,43,45,48,50],{"name":40,"role":21,"phone":41,"phoneExt":10,"email":42},"Anna Soteras Prat","+34 933 26 31 90","asoteras@barcelonabeta.org",{"name":20,"role":44,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":46,"role":47,"phone":10,"phoneExt":10,"email":10},"Oriol Grau-Rivera, MD, PhD","SUB_INVESTIGATOR",{"name":49,"role":47,"phone":10,"phoneExt":10,"email":10},"Gonzalo Sánchez Benavides, PhD",{"name":51,"role":47,"phone":10,"phoneExt":10,"email":10},"Ana Fernández Arcos, MD, PhD",{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[55,57],{"name":56,"class":6},"Hospital del Mar",{"name":58,"class":59},"Hospital del Mar Research Institute","UNKNOWN","100649136","pensa-extended-follow-up-of-a-multimodal-lifestyle-intervention-to-prevent-cognitive-decline-in-apoe-4-carriers-100649136",false,"NCT07730671","PENSA+: Extended Follow-up of a Multimodal Lifestyle Intervention to Prevent Cognitive Decline in APOE-ε4 Carriers","Evaluation of the Long-Term Cognitive, Biological, and Lifestyle Effects of a Multimodal Intervention for Preventing Cognitive Decline in APOE-ε4 Carriers With Subjective Cognitive Decline","PENSA+","Inclusion Criteria\n\n\\- Any individual who has completed the PENSA study, does not meet any exclusion criteria, and provides consent is eligible to participate in this study.\n\nExclusion Criteria\n\nParticipants will be excluded from the study if they meet any of the following conditions:\n\n* A prior clinical diagnosis of dementia, regardless of etiology.\n* Current institutionalization (e.g., residence in nursing homes, long-term care facilities, or similar institutions).\n* Impaired decision-making capacity, defined as the inability to provide informed consent independently due to cognitive, legal, or medical reasons (e.g., loss of autonomy or requirement of a legal representative).\n* Current participation in another interventional clinical trial, or participation in an interventional clinical trial within the previous 3 months prior to baseline; unless deemed by the investigator not to interfere with PENSA+ procedures or outcomes.","ALL","60 Years",{"count":71,"type":72},121,"ESTIMATED","OBSERVATIONAL","PENSA+ is a 5-year follow-up study of participants who previously completed the PENSA clinical trial (NCT03978052), which evaluated an intensive multimodal lifestyle intervention, with or without epigallocatechin gallate (EGCG), in APOE-ε4 carriers with subjective cognitive decline, a population at increased risk of developing Alzheimer's disease.\n\nThe purpose of this study is to determine whether the cognitive, biological, and lifestyle benefits observed after the original intervention are maintained over the long term. Researchers will evaluate cognitive performance, the incidence of mild cognitive impairment, dementia risk, brain imaging, blood biomarkers, physical fitness, lifestyle behaviors, and psychosocial factors approximately five years after completion of the intervention.\n\nThe study will also investigate the biological and behavioral mechanisms associated with sustained cognitive benefit, identify participant characteristics associated with better long-term outcomes, evaluate the long-term cost-effectiveness of the intervention using healthcare utilization data, and explore whether lifestyle changes have influenced participants' study partners. No new intervention will be administered as part of this follow-up study.",[76],"Subjective Cognitive Decline (SCD)",[78,79,80,81,82,83,84,85,86,76],"Alzheimer's Disease","Dementia Prevention","Subjective Cognitive Decline","APOE-ε4 carriers","Multidomain Lifestyle Intervention","Epigallocatechin Gallate (EGCG)","Brain Health","Blood Biomarkers","Long-Term Follow-up","NOT_YET_RECRUITING","2026-07-27",{"date":90,"type":91},"2026-07-28","ACTUAL",{"date":93,"type":72},"2026-09-01",{"date":95,"type":72},"2028-09",{"name":5,"class":6},1]